Deviation Impact Assessment
Equipment Details
Equipment: Implant Inspection System
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation:
Classification
Classification of Deviation:
Minor
Major
Critical
Product/Patient Impact
Impact Description:
Data Integrity Impact
Impact Description:
Affected Batches/Studies
List of Affected Batches/Studies:
Investigation
Investigation Summary:
CAPA (Corrective and Preventive Action)
CAPA Details:
Re-test/Requalification Decision
Decision:
QA Disposition
Disposition: